MAUDE Adverse Event Report: Edwards Lifesciences Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve; Aortic valve, prosthesis, percutaneously delivered

Model Number	9755RSL29A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2026
Type of Reportable Event	Malfunction

• Brand Name: Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve
• Common Device Name: Aortic valve, prosthesis, percutaneously delivered
• Manufacturer (Section D): Edwards Lifesciences; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): Edwards Lifesciences; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; +1(949)250-6385
• MDR Report Key: 50000322
• Report Number: 2015691-2026-17091
• Device Sequence Number: 13426660
• Product Code: NPT
• UDI-Device Identifier: 00690103215823
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P140031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9755RSL29A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/02/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2026
• Supplement Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 396 LB